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In Reply: Dr Levine and Mr Kohanyi state that with regard to the St Jude Medical Trilogy pacemaker advisory, "the failure rate based on our analysis of returned devices was not underestimated." As stated in the Commentary, it is often difficult to estimate the true incidence of an observed malfunction. The data from Levine's own editorial¹ regarding the St Jude Medical Trilogy pacemaker advisory were accurately cited in the Commentary as an example of this difficulty.

It is instructive to review the Trilogy example in detail as outlined in a US Food and Drug Administration (FDA) investigation in response to a patient complaint.^2-3 St Jude Medical became aware of the Trilogy problem in early 1997 via analysis of explanted field returns.³ By October 1998, the manufacturer understood the problem and validated a fix and a month later the FDA approved the proposed remedy.³ St Jude Medical implemented the fix in . . . [Full Text of this Article]

William H. Maisel, MD, MPH
wmaisel@bidmc.harvard.edu
Cardiovascular Division
Beth Israel Deaconess Medical Center
Harvard Medical School
Boston, Mass

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